The Effect of Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

The Effect of Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200951
• Other study ID #: 4-2017-0341
• Status: Completed
• Phase: N/A
• Start date: August 22, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: October 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to evaluate the effect of epidural block on intracranial pressure in pediatric patients with cerebral palsy undergoing osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural block before osteotomy will be divided into bolus group (n=20) and infusion group (n=20). Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block. The primary endpoint is the difference in the optic nerve sheath diameter after epidural block measured by optic nerve ultrasonography between groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 13 Years

Eligibility

Inclusion Criteria:

• Pediatric patients with cerebral palsy from 4 to 13 years of age undergoing osteotomy

• Body weight = 40 kg

Exclusion Criteria:

• Patients with contraindications to epidural analgesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)

• Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure

• Patients with ophthalmic disease or surgery

• The estimated operation time is less than 70 minutes.

• All parents of the subject are foreigners or illiterate

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Drug:
• Bolus group for epidural block
Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block.
• Infusion group for epidural block
Randomly selected patients of the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Lin Y, Li Q, Liu J, Yang R, Liu J. Comparison of continuous epidural infusion and programmed intermittent epidural bolus in labor analgesia. Ther Clin Risk Manag. 2016 Jul 14;12:1107-12. doi: 10.2147/TCRM.S106021. eCollection 2016. — View Citation

Padayachy LC, Padayachy V, Galal U, Pollock T, Fieggen AG. The relationship between transorbital ultrasound measurement of the optic nerve sheath diameter (ONSD) and invasively measured ICP in children. : Part II: age-related ONSD cut-off values and patency of the anterior fontanelle. Childs Nerv Syst. 2016 Oct;32(10):1779-85. doi: 10.1007/s00381-016-3068-4. Epub 2016 Sep 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the optic nerve sheath diameter(ONSD) between groups	The optic nerve sheath diameter measured by optic nerve ultrasonography.	5 minutes before epidural block
Primary	The difference in the optic nerve sheath diameter(ONSD) between groups	The optic nerve sheath diameter measured by optic nerve ultrasonography.	1 second after epidural block
Primary	The difference in the optic nerve sheath diameter(ONSD) between groups	The optic nerve sheath diameter measured by optic nerve ultrasonography.	10 minutes after epidural block
Primary	The difference in the optic nerve sheath diameter(ONSD) between groups	The optic nerve sheath diameter measured by optic nerve ultrasonography.	70 minutes after epidural block
Secondary	The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups	The optic nerve sheath diameter measured by optic nerve ultrasonography	5 minutes before epidural block
Secondary	The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups	The optic nerve sheath diameter measured by optic nerve ultrasonography	1 second after epidural block
Secondary	The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups	The optic nerve sheath diameter measured by optic nerve ultrasonography	10 minutes after epidural block
Secondary	The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups	The optic nerve sheath diameter measured by optic nerve ultrasonography	70 minutes after epidural block